Town Hall – Biocompatibility and Chemical Characterization Testing – Extractions

The U.S. Food and Drug Administration (FDA) will host a town hall for industry professionals and other interested stakeholders to discuss chemical characterization testing methodologies used to address biocompatibility endpoints for medical devices. The session will focus on approaches for conducting extractions for chemical characterization testing in accordance with ISO 10993-18, while also highlighting common challenges and practical examples related to these testing processes.

Participants will explore considerations for evaluating the potential biological response to device materials within a risk-based framework. Discussions will also address FDA’s ongoing efforts to support biocompatibility assessments in a manner that is intended to be efficient and least burdensome for both medical device manufacturers and regulatory reviewers.

Visit the event page for more information.